Z-0612-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- November 7, 2018
- Termination Date
- September 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146
Product Description
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Reason for Recall
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Code Information
All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2